Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy (FIBERTRACH)
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| ClinicalTrials.gov Identifier: NCT04265625 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2020
Last Update Posted : September 21, 2023
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Tracheostomy is one of the most frequently performed techniques in intensive care units. For some authors endoscopic guide as part of the percutaneous tracheostomy (PT) might reduces the incidence of serious complications. However, for others, endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during PT in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the results of six published nation surveys. Extensive randomized trials to compare PT with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis: Percutaneous tracheotomy performed under endoscopic guide decreases the incidence of perioperative complications of the procedure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tracheostomy Complication | Device: endoscopic guidance | Not Applicable |
Background
Tracheostomy is one of the most frequently performed techniques in intensive care units (ICU). A few years after the description of the percutaneous dilatational tracheostomy (PDT), endoscopic guide as part of the technique was performed in four patients. The authors concluded that the endoscopic guide provided advantages to the realization of PDT. Other authors have state that endoscopy, significantly reduces the incidence of serious complications such as posterior tracheal tears, false passage, pneumothorax and subcutaneous emphysema. However, currently endoscopic guide as part of the percutaneous tracheostomy is controversial. Although for some authors its use reduces the number of complications, others found that endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. Thus, some do not consider it necessary when the physicians have enough experience with percutaneous tracheostomy. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during percutaneous tracheostomy in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the published surveys. Specifically, in Spain its use was the lowest of the six published nation surveys. Extensive randomized trials to compare percutaneous tracheostomy with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis
Percutaneous tracheotomy performed under endoscopic guidance decreases the incidence of perioperative complications of the procedure.
Main goal
- - To assess the incidence of perioperative complications of percutaneous tracheotomy under endoscopic guide versus blind percutaneous tracheotomy.
- - To assess the ventilatory parameters during percutaneous tracheostomy with and without endoscopic control.
Methodology
Prospective, multicenter randomized study. Patients admitted to the ICU who need tracheostomy due to prolonged mechanical ventilation, who do not have neither contraindications to perform the percutaneous technique nor contraindications to perform fibrobronchoscopy will be randomized.
The percutaneous tracheostomy will be carried out with the single-step dilation method. For its realization, the usual protocol will be followed.
The included patients will be randomized 1:1 (percutaneous tracheostomy with endoscopic guide vs percutaneous tracheostomy without endoscopic guide). The randomization system will be by closed envelope. A sample size of 221 patients in each branch has been calculated.
The percutaneous tracheostomy and fiberoptic bronchoscopy will be performed by staff with experience with both procedures.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 442 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Role of Routine Fiberoptic Bronchoscopic Guidance During Percutaneous Tracheostomy. A Prospective Randomized Trial |
| Actual Study Start Date : | December 7, 2019 |
| Estimated Primary Completion Date : | February 28, 2024 |
| Estimated Study Completion Date : | April 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: blind tracheotomy
no endoscopic guidance tracheotomy
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Experimental: endoscopic guidance tracheotomy
With endoscopic guidance tracheotomy
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Device: endoscopic guidance
Percutaneous tracheotomy performed by endoscopic guidance |
- Number of patients with bleeding [ Time Frame: 24 hours ]Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells.
- Number of patients with hypoxemia [ Time Frame: During the procedure ]Hypoxemia: Oxygen arterial saturation (SaO2) < 85% during more than 90 seconds and/or arrhythmia or cardiac arrest related to hypoxemia.
- Number of patients in whom a loss of airway has ocurred [ Time Frame: During the procedure ]Loss of airway: Failure to be able to access the airway > 30 seconds.
- Number of patients with atelectasis [ Time Frame: 24 hours ]Atelectasis: Total or partial lung collapse not present before the technique, evidenced at postoperative control.
- Number of patients with hypotension [ Time Frame: During the procedure ]Hypotension requiring treatment with vasopressors or >1000 ml of fluids during the procedure.
- Number of patients with barotrauma [ Time Frame: 24 hours ]Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique.
- Number of patients with posterior tracheal wall injury [ Time Frame: During the procedure ]Posterior tracheal wall injury: Injury to membranous trachea from needle, guide or dilator.
- Number of patients in whom false passage has ocurred [ Time Frame: During the procedure ]False passage: Dilatation or insertion of the cannula out of the trachea lumen.
- Peak airway pressure [ Time Frame: During the procedure ]Maximum peak airway pressure (cmH2O)
- Plateau pressure [ Time Frame: During the procedure ]Maximum plateau pressure (cmH2O)
- Tidal volume [ Time Frame: During the procedure ]Minimum tidal volume (mL)
- Arterial Blood Gas [ Time Frame: 2 hours ]Arterial blood gase at the beginning and the end of the procedure
- Oxygen saturation (SaO2) [ Time Frame: During the procedure ]Minimum arterial oxygen saturation (SaO2)
- Mortality [ Time Frame: 90 days ]All-cause mortality at hospital discharge
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients over 18 years old requiring tracheotomy due to prolonged mechanical ventilation
- That Family members or legal representatives have signed the information sheet and informed consent
Exclusion Criteria:
- Patients with increased intracranial pressure according to intracranial pressure monitoring or suspected.
- Patients who have any absolute or relative contraindication for the percutaneous tracheostomy realization
- Patients with difficult airway
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265625
| Contact: Jose Manuel Añon, MD, PhD | +(34) 912071307 | jmaelizalde@gmail.com |
| Spain | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Contact: Jose M. Añon, MD,PhD +(34) 912071307 jmaelizalde@gmail.com | |
| Hospital Universitario Infanta Leonor | Recruiting |
| Madrid, Spain | |
| Contact: Covadonga Rodriguez, MD covarodriguezruiz@gmail.com | |
| Hospital Universitario Rey Juan Carlos | Recruiting |
| Madrid, Spain | |
| Contact: Manuel Perez-Marquez, MD mapemar@msn.com | |
| Sub-Investigator: Manuel Perez-Marquez, MD | |
| Hospital Universitario de Toledo | Recruiting |
| Toledo, Spain | |
| Contact: Margarita Marquez, MD margui1992@hotmail.com | |
| Principal Investigator: | Jose Manuel Añon, MD. PhD | Hospital Universitario La Paz. IdiPAZ |
Publications:
| Responsible Party: | José Manuel Añón, MD,PhD, Instituto de Investigación Hospital Universitario La Paz |
| ClinicalTrials.gov Identifier: | NCT04265625 |
| Other Study ID Numbers: |
HULP5455 |
| First Posted: | February 11, 2020 Key Record Dates |
| Last Update Posted: | September 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Percutaneous tracheostomy, Fiberoptic bronchoscopic guidance |